Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 / Notices 36901

Regulatory Action Leader Office location/telephone number Address

Driss Benmhend ............ Rm. 37, 9th floor, CM #2, 703–308–9525, e-mail:

benmhend.driss@epamail.epa.gov.

1921 Jefferson Davis Hwy, Arlington, VA

Sheila Moats .................. Rm. 14, 9th floor, CM #2, 703–308–1259, e-mail: moats.sheila@epamail.epa.gov. Do.

SUPPLEMENTARY INFORMATION:

Electronic Availability: Electronic

copies of this document and the Fact

Sheet are available from the EPA home

page at the Federal RegisterEnvironmental Documents entry for this

document under ‘‘Laws and

Regulations’’ (http://www.epa.gov/

fedrgstr/).

EPA issued a notice, published in the

Federal Register of January 22, 1997 (62

FR 3287) (FRL–5582–4), which

announced that Themac Incorporation

P.O. Box 5209, Valdosta, GA 31603–

5209, had submitted an application to

register the pesticide product Game

Stop a vertebrate repellent (EPA File

Symbol 70061–R), containing the new

active ingredient fish oil at 11.6 percent,

an active ingredient not included in any

previously registered product.

The application was approved on

March 6, 1998, as Game Stop, (EPA

Registration Number 70061–1) for

terrestrial use application of liquid

formulation to foliage and twigs of trees,

shrubs, and ornamental plants which

are fed upon by rabbits and deer. (S.

Moats)

EPA also published a notice in the

Federal Register of October 30, 1997 (62

FR 58729) (FRL–5751–4), which

announced that Engelhard Corporation,

101 Wood Avenue, Iselin, NJ 08830, had

submitted applications to register the

pesticide products M-97-002, M-97-009,

and M-96-018 (EPA File Symbols

70060–E, 70060–R, and 70060–G)

containing the active ingredient kaolin

at 99.4, 100, and 98.8 percent

respectively, an active ingredient not

included in any previously registered

products.

The applications for these products

were approved on March 17, 1998, as

M-97-002 Kaolin, M-97-009 Kaolin, and

M-97-018 Kaolin, as a broad spectrum

agricultural repellent/protectant for

controlling damage to crops from

various insects, mites, fungal, and

bacterial diseases (EPA Registration

Numbers 70060–2, 70060–1, and 70060–

3), respectively. (D. Benmhend)

The Agency has considered all

required data on risks associated with

the proposed use of fish oil and kaolin,

and information on social, economic,

and environmental benefits to be

derived from use. Specifically, the

Agency has considered the nature of the

chemical and its pattern of use,

application methods and rates, and level

and extent of potential exposure. Based

on these reviews, the Agency was able

to make basic health safety

determinations which show that use of

fish oil and kaolin when used in

accordance with widespread and

commonly recognized practice, will not

generally cause unreasonable adverse

effects to the environment.

More detailed information on these

registrations is contained in an EPA

Pesticide Fact Sheet on fish oil and

kaolin.

A copy of these fact sheets, which

provide a summary description of the

pesticides, use patterns and

formulations, science findings, and the

Agency’s regulatory position and

rationale, may be obtained from the

National Technical Information Service

(NTIS), 5285 Port Royal Road,

Springfield, VA 22161.

In accordance with section 3(c)(2) of

FIFRA, a copy of the approved label, the

list of data references, the data and other

scientific information used to support

registration, except for material

specifically protected by section 10 of

FIFRA, are available for public

inspection in the Public Information

and Records Integrity Branch,

Information Resources and Services

Division (7502C), Office of Pesticide

Programs, Environmental Protection

Agency, Rm. 119, CM #2, Arlington, VA

22202 (703–305–5805). Requests for

data must be made in accordance with

the provisions of the Freedom of

Information Act and must be addressed

to the Freedom of Information Office (A101), 401 M St., SW., Washington, D.C.

20460. Such requests should: (1)

Identify the product name and

registration number and (2) specify the

data or information desired.

Authority: 7 U.S.C. 136.

List of Subjects

Environmental protection, Pesticides

and pests, Product registration.

Dated: June 24, 1998.

Janet L. Andersen,

Director, Biopesticides and Pollution

Prevention Division, Office of Pesticide

Programs.

[FR Doc. 98–18079 Filed 7–7–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[PF–808; FRL–5791–6]

Notice of Filing of a Pesticide Petition

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

initial filing of a pesticide petition

proposing the establishment of

regulations for residues of certain

pesticide chemicals in or on various

food commodities.

DATES: Comments, identified by the

docket control number PF–808, must be

received on or before August 7, 1998.

ADDRESSES: By mail submit written

comments to: Public Information and

Records Integrity Branch (7502C),

Information Resources and Services

Division, Office of Pesticides Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460. In

person bring comments to: Rm. 119, CM

#2, 1921 Jefferson Davis Highway,

Arlington, VA.

Comments and data may also be

submitted electronically to: oppdocket@epamail.epa.gov. Follow the

instructions under ‘‘SUPPLEMENTARY

INFORMATION.’’ No confidential

business information should be

submitted through e-mail.

Information submitted as a comment

concerning this document may be

claimed confidential by marking any

part or all of that information as

‘‘Confidential Business Information’’

(CBI). CBI should not be submitted

through e-mail. Information marked as

CBI will not be disclosed except in

accordance with procedures set forth in

40 CFR part 2. A copy of the comment

that does not contain CBI must be

submitted for inclusion in the public

record. Information not marked

confidential may be disclosed publicly

by EPA without prior notice. All written

comments will be available for public

inspection in Rm. 119 at the address

given above, from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays.

FOR FURTHER INFORMATION CONTACT: By

mail: Richard W. King, Regulatory

Action Leader, Biopesticides and

Pollution Prevention Division, (7511C),

Office of Pesticide Programs,
36902 Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 / Notices

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460.

Office location and telephone number:

Rm. 14, 9th floor, CM #2, 1921 Jefferson

Davis Highway, Arlington, VA. 22202,

(703) 308–8052; e-mail:

king.richard@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA has

received a pesticide petition as follows

proposing the establishment and/or

amendment of regulations for residues

of certain pesticide chemicals in or on

various food commodities under section

408 of the Federal Food, Drug, and

Comestic Act (FFDCA), 21 U.S.C. 346a.

EPA has determined that the petition

contains data or information regarding

the elements set forth in section

408(d)(2); however, EPA has not fully

evaluated the sufficiency of the

submitted data at this time or whether

the data supports granting of the

petition. Additional data may be needed

before EPA rules on the petition.

The official record for this notice of

filing, as well as the public version, has

been established for this notice of filing

under docket control number [PF–808]

(including comments and data

submitted electronically as described

below). A public version of this record,

including printed, paper versions of

electronic comments, which does not

include any information claimed as CBI,

is available for inspection from 8:30

a.m. to 4 p.m., Monday through Friday,

excluding legal holidays. The official

record is located at the address in

‘‘ADDRESSES’’ at the beginning of this

document.

Electronic comments can be sent

directly to EPA at:

opp-docket@epamail.epa.gov

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Comment and data will

also be accepted on disks in

Wordperfect 5.1/6.1 or ASCII file

format. All comments and data in

electronic form must be identified by

the docket control number [PF–808] and

appropriate petition number. Electronic

comments on this notice may be filed

online at many Federal Depository

Libraries.

List of Subjects

Environmental protection,

Agricultural commodities, Food

additives, Feed additives, Pesticides and

pests, Reporting and recordkeeping

requirements.

Dated: June 29, 1998.

Kathleen D. Knox,

Acting Director, Biopesticides and Pollution

Prevention Division, Office of Pesticide

Programs.

Summaries of Petitions

Petitioner summaries of the pesticide

petitions are printed below as required

by section 408(d)(3) of the FFDCA. The

summaries of the petitions were

prepared by the petitioners and

represent the views of the petitioners.

EPA is publishing the petition

summaries verbatim without editing

them in any way. The petition summary

announces the availability of a

description of the analytical methods

available to EPA for the detection and

measurement of the pesticide chemical

residues or an explanation of why no

such method is needed.

Asahi Chemical Manufacturing

Company

PP 7F4835

EPA has received a pesticide petition

(PP 7F4835) from Asahi Manufacturing

Company, Ltd., c/o Chemical

Consultants International, Inc., 7270

West 98th Terrace, Suite 100, Overland

Park, KS, 66212, proposing pursuant to

section 408(d) of the Federal Food,

Drug, and Cosmetic Act, 21 U.S.C.

346a(d), to amend 40 CFR part 180 to

establish an amendment/expansion of

an existing tolerance exemption for the

biochemical pesticide Sodium oNitrophenolate, Sodium pNitrophenolate, and Sodium 5-

Nitroguaiacolate in or on all crops.

Pursuant to section 408(d)(2)(A)(i) of

the FFDCA, as amended, Asahi

Manufacturing Company, Ltd. has

submitted the following summary of

information, data and arguments in

support of their pesticide petition. This

summary was prepared by Asahi

Manufacturing Company, Ltd. and EPA

has not fully evaluated the merits of the

petition. The summary may have been

edited by EPA if the terminology used

was unclear, the summary contained

extraneous material, or the summary

was not clear that it reflected the

conclusion of the petitioner and not

necessarily EPA.

A. ATONIK and Proposed Use

Practices

ATONIK is registered for use as a

plant growth stimulator on cotton, rice

and soybeans. Application should be

made with the addition of a non-ionic

surfactant.

1. Cotton. ATONIK may be applied

twice during the growing season in 40

to 60 gallons of water per acre.

ATONIK may be applied at 8 fluid

ounces per acre at first bloom with a

second application at 14 fluid ounces

during early boll development.

2. Rice. ATONIK may be applied

twice during the growing season in 40

to 60 gallons of water. ATONIK may be

applied at 6 to 8 fluid ounces per acre

at the beginning of panicle initiation

with a second application of 6 to 8 fluid

ounces at post anthesis.

3. Soybeans. ATONIK may be

applied twice during the growing season

in 40 to 60 gallons of water. ATONIK

may be applied at 6 to 8 fluid ounces

per acre 5 days after first bloom with a

second application of 6 to 8 fluid

ounces 3 to 4 weeks after first bloom.

B. Product Identity/Chemistry

ATONIK is comprised of three active

ingredients. These three active

ingredients have each been exempted

from the requirements of tolerance for

cotton, rice and soybeans. The three

active ingredients and the percentage of

each in ATONIK are:

i. Sodium o-Nitrophenolate 0.20%

ii. Sodium p-Nitrophenolate 0.30%

iii. Sodium 5-Nitroguaiacolate 0.10%

The Chemical properties of each of

the three ingredients in ATONIK and

of ATONIK itself are presented in

section A of the submission. The three

active ingredients have all been shown

to be taken up into plants and

immediately metabolized. Therefore, no

measurable residues have been found or

will be expected.

C. Mammalian Toxicological Profile

Acute toxicology studies place

ATONIK in Category IV. Acute

toxicology studies place Sodium oNitrophenolate in Category II based

upon the results of the primary eye

study, Sodium p-Nitrophenolate is in

Category II based upon the results of the

acute oral and the primary eye studies

and Sodium 5-Nitroguaiacolate is in

Category I based upon the results of the

primary eye study. ATONIK was found

to be a mild sensitizer in the guinea pig.

A subchronic oral feeding study was

performed on the end-use product

ATONIK using dietary dose levels of 0,

5,000, 15,000 and 50,000 parts per

million (ppm), which was equivalent to

515, 1,590, and 5,056 milligrams/

kilograms (mg/kg/day) for male rats and

531, 1,723, and 6,553 mg/kg/day for

female rats. The lowest observed effect

level (LOEL) was 1,589 mg/kg/day for

male rats and 1,723 mg/kg/day for

female rats based upon decreased

weight gains, changes in hematology

parameters, relative organ weights of the

liver and kidney, and pigment

accumulation in kidney and spleen.
Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 / Notices 36903

A developmental toxicity study in rats

was conducted on ATONIK.

Administration was by gavage at dose

levels of 0, 100, 300, and 600 mg/kg/

day. Significantly decreased body

weight gain and food consumption was

observed at 600 mg/kg/day in the female

rats. One death was noted and attributed

to the test chemical. The maternal no

observed effect level (NOEL) and LOEL

were determined to be 300 and 600 mg/

kg/day, respectively. No developmental

toxicity was observed. The NOEL for

developmental toxicity was determined

to be 600 mg/kg/day.

The Ames Test, Mouse Micronucleus

Assay and the Mouse Lymphoma Assay

were each performed with each of the

three active ingredients in ATONIK.

All results were negative.

The toxicity studies are sufficient to

demonstrate that there are no

foreseeable human or domestic animal

health hazards possible from use of

these active ingredients as plant

regulators in the concentrations present

in ATONIK.

D. Aggregate Exposure

The end-use product, ATONIK,

contains the three active ingredients in

very low concentrations. At the

application rates employed, the level of

active ingredient which may be present

in any of the food or feed items would

be far below the levels which

demonstrated any effects in the

subchronic oral feeding study, the

developmental toxicity study or the

mutagenicity studies. It can be shown

that in order to reach a dose rate

comparable to the LOEL of 1,600 mg/kg/

day obtained in the subchronic oral

feeding study, a person weighing 50 kg

would have to consume all of the

produce from 4 acres of crop every day.

Further, due to the rapid uptake and

metabolism of the three active

ingredients in the plants, it is most

unlikely that any of the residue would

be available for potential exposure.

Similarly, exposure of the residues to

humans from consumption of water

would be equally unlikely. There is no

allowed use of the product containing

the three active ingredients on lawns,

rights-of-way, golf courses, or other

areas where human exposure may

result. Therefore, exposure from these

areas would be non-existent.

E. Cumulative Exposure

Exposure through other pesticides

and substances with the same mode of

toxicity is not likely. What little toxicity

that is observed is only observed at

extremely high concentrations of these

active ingredients.

F. Safety Determination

The three active ingredients in the

end-use product, ATONIK, are all

biochemicals. The low toxicity of each

of these alone and in combination, as

discussed above, demonstates that these

chemicals, at the rates established, will

not pose any known risk to human

health, either as children or as adults.

These three active ingredients are

already exempted from the requirements

of a tolerance for use on cotton, rice and

soybeans.

G. Effects on the Immune and Endocrine

Systems

The Agency has no information to

suggest that ATONIK will have an

effect on the immune and endorine

systems. The Agency is not requiring

information on the endocrine effects of

this biological pesticide at this time.

Congress has allowed 3 years after

August 3, 1996, for the Agency to

implement a screening program with

respect to endocrine effects.

H. Existing Tolerances

Exemptions from the requirements of

a tolerance have already been

established for residues of the

biochemical plant regulators Sodium oNitrophenolate, Sodium pNitrophenolate, and Sodium 5-

Nitroguaiacolate in or on the raw

agricultural commodities cottonseed,

cotton gin by products, rice, rice straw,

soybeans, and soybean forage and hay.

I. International Tolerances

No known international tolerances

have been granted for this pesticide.

Therefore, based on the completeness

and reliability of the toxicity data from

the published literature and

conservative exposure assessment,

Asahi Manufacturing Company, Ltd.,

concludes that there is a reasonable

certainty that no harm will result from

aggregate exposure to residues of the

ATONIK including all anticipated

dietary exposure and all nonoccupational exposures.

[FR Doc. 98–18076 Filed 7–7–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[OPP–50842; FRL–5798–4]

Issuance of an Experimental Use

Permit

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: EPA has granted an

experimental use permit to the

following applicant. The permit is in

accordance with, and subject to, the

provisions of 40 CFR part l72, which

defines EPA procedures with respect to

the use of pesticides for experimental

use purposes.

FOR FURTHER INFORMATION CONTACT: By

mail: Sheila Moats, Biopesticides and

Pollution Prevention Division (7511C),

Office of Pesticide Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460.

Office location, telephone number, and

e-mail address: 9th Floor, CM #2, 1921

Jefferson Davis Highway, Arlington, VA,

(703) 308–1259, e-mail:

moats.sheila@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA has

issued the following experimental use

permit:

70515–EUP–1. Issuance. J P

BioRegulators, Inc., IR-4 Project Rutgers

University, Cook College, P.O. Box 231,

New Brunswick, NJ 08903–0231. This

experimental use permit allows the use

of 72 kilograms each year for the

biochemical phospholipid: Lyso-PE

(lysophosphatidylethanolamine) on 520

acres of apples, citrus, cranberries,

grapes, peaches, pears, nectarines,

strawberries, and tomatoes to evalaute

pre-harvest and post-harvest ripening

and storage shelf-life. The program is

authorized only in the States of Arizona,

California, Florida, Massachusetts,

Michigan, Ohio, Washington, West

Virginia, and Wisconsin. The program is

effective from June 3, 1998 to June 1,

2001.

Persons wishing to review this

experimental use permit are referred to

the designated contact person. Inquires

concerning this permit should be

directed to the person cited above. It is

suggested that interested persons call

before visiting the EPA office, so that

the appropriate file may be made

available for inspection purposes from 8

a.m. to 4 p.m., Monday through Friday,

excluding legal holidays.

Authority: 7 U.S.C. 136.

List of Subjects

Environmental protection,

Experimental use permits.

Dated: June 24, 1998.

Janet L. Andersen,

Director, Biopesticides and Pollution

Prevention Division, Office of Pesticide

Programs.

[FR Doc. 98–18077 Filed 7–7–98; 8:45 am]

BILLING CODE 6560–50–F